Safety and Dose-finding Study of DC-TAB in Healthy Subjects

NCT02442557 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2015-05-13

No results posted yet for this study

Summary

The purpose of this study is to determine safety and appropriate dose of DC-TAB for selective immune tolerance induction in humans.

Conditions

Interventions

BIOLOGICAL

recombinant human alpha B-crystallin

intravenous injection

OTHER

placebo comparator

intravenous injection

Sponsors & Collaborators

  • Delta Crystallon BV

    lead INDUSTRY

Principal Investigators

  • Floris Höppener, PhD, MD · Syneos Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2010-10-31
Completion
2011-07-31

Countries

  • Netherlands

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02442557 on ClinicalTrials.gov